Medical devices, 2016
Shortlist up to four to read them side by side.
3,246 medical device recalls FDA’s Enforcement Report published in 2016, newest first; 40,450 in all since 2012.
FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 6, 2026.
3,246of 3,246 medical device recallsshown with your filters
The list
- Medical device recall SB (Sumitomo Bakelite Co.,) Electrosurgical Knife Size: Working Length 1.8M Maximum OD 2.6mm Mislabeled product: Sterilization pouch and carton labeled as Standard Type instead of Short type Class IIFDA’s classNov 16, 2016in FDA’s Enforcement ReportMassachusettsthe one state its words name PublishedNov 16, 2016ClassClass IIStatusTerminatedWhereMassachusetts
- Medical device recall Accessory Adapter Maquet Inc. Class IIFDA’s classNov 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedNov 16, 2016ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, District of Columbia, Michigan, Missouri and Pennsylvania named
- Medical device recall OR Table, Top U26 H V Trumpf has identified six incidents of pinched cables. Class IIFDA’s classNov 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedNov 16, 2016ClassClass IIStatusTerminatedWhereNationwide, and Arizona and South Carolina named
- Medical device recall ReShape Integrated Dual Balloon System, Gen 1 ReShape Medical is recalling the Integrated Dual Balloon System Gen 1 due to the potential leak of distillation fluid during balloon inflation. Class IIFDA’s classNov 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedNov 16, 2016ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Georgia, Illinois, Indiana, Louisiana, Massachusetts, Missouri, New York, Ohio, Tennessee and Texas named
- Medical device recall NRG Transseptal Needle and NRG RF Transseptal Kit The firm is voluntarily recalling lots of the NRG Transseptal Needle and NRG RF Transseptal Kit due to the possibility for an integrity defect to the Tyvek… Class IIFDA’s classNov 16, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 16, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall catalog # 405612 BD Spinal Anesthesia Tray 22G x 3.5 in A recall was initiated by Hospira, Inc. Class IIFDA’s classNov 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 16, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 15 g R.K. Epidural Needle (TW), Catalog #/REF #100-1415 Intended for the epidural placement, directly or… There is a possibility that the needles may have the potential to skive a catheters outer coating. Class IIFDA’s classNov 9, 2016in FDA’s Enforcement Report6 statesnamed in where it went PublishedNov 9, 2016ClassClass IIStatusTerminatedWhereAlaska, Alabama, Florida, Indiana, Tennessee and Texas
- Medical device recall TD60 display Telemetry Transmitter, SHENZHEN Mindray Bio-Medical Electronics Co., LTD, Mindray Building, Keji… Mindray has become aware that the TD60 Display Telemetry Transmitter used with the BeneVision Central Station may crack on the bezel surrounding the display… Class IIFDA’s classNov 9, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 9, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Visualase Visualization Stylets PN 020-2301 Medtronic Navigation, Inc. Class IIFDA’s classNov 9, 2016in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 9, 2016ClassClass IIStatusTerminatedWhereCalifornia, Florida, Georgia and Texas
- Medical device recall Visualase Body Accessory Kit PN 020-3000 Medtronic Navigation, Inc. Class IIFDA’s classNov 9, 2016in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 9, 2016ClassClass IIStatusTerminatedWhereCalifornia, Florida, Georgia and Texas
- Medical device recall Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs… Issue with the process for detection of leaking Pressure Tourniquet Cuffs (PTC). Class IIFDA’s classNov 9, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 9, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Empowr PS Knee System Box Cut Guide It has been discovered that during Empowr PS Total Knee replacement, while chiseling for bone removal in the box area, femoral chipping has occurred in surgery. Class IIFDA’s classNov 9, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 9, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Product Number 3102071 Ceiling Bracket, Arch 71 White with use on ceiling installed rail systems: Multirall… Ceiling Bracket 71 was shipped with a larger center hole. Class IIFDA’s classNov 9, 2016in FDA’s Enforcement Report5 statesnamed in where it went PublishedNov 9, 2016ClassClass IIStatusTerminatedWhereMichigan, North Carolina, Ohio, Pennsylvania and Washington
- Medical device recall Affected Pain Control Tray Component B. Class IIFDA’s classNov 9, 2016in FDA’s Enforcement Report6 statesnamed in where it went PublishedNov 9, 2016ClassClass IIStatusTerminatedWhereAlabama, Illinois, Massachusetts, Minnesota, Oklahoma and Wisconsin
- Medical device recall Glucose Tolerance Beverage- Orange 50 gram Concentration, Liquid 4/Pack of 6 bottles, 24/case Accessory to an… Out of Specification Microbiological test results Class IIFDA’s classNov 9, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 9, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Fruit Punch Glucose, 100 Gram Concentration, Liquid, 4/Pack of 6 Bottles, 24/cs Accessory to an In Vitro… Out of Specification Microbiological test results Class IIFDA’s classNov 9, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 9, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall HANDS-OFF Infusion Port Thermodilution Catheter consists of the Arrow IPTD thermodilution catheter enclosed… Labeling inconsistency Class IIFDA’s classNov 9, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 9, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Xhibit Central Station The firm received reports of telemetry SpO2 numerics dropping off the Xhibit Central display. Class IIFDA’s classNov 9, 2016in FDA’s Enforcement Report28 statesnamed in where it went PublishedNov 9, 2016ClassClass IIStatusTerminatedWhereAlabama, California, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Michigan, Minnesota, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Texas, Virginia, Washington and Wyoming
- Medical device recall Guider Softip XF Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product. Class IIFDA’s classNov 9, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedNov 9, 2016ClassClass IIStatusTerminatedWhereAlaska, Illinois and Ohio
- Medical device recall Guider Softip XF Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product. Class IIFDA’s classNov 9, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedNov 9, 2016ClassClass IIStatusTerminatedWhereAlaska, Illinois and Ohio
- Medical device recall Guider Softip XF Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product. Class IIFDA’s classNov 9, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedNov 9, 2016ClassClass IIStatusTerminatedWhereAlaska, Illinois and Ohio
- Medical device recall Guider Softip XF Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product. Class IIFDA’s classNov 9, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedNov 9, 2016ClassClass IIStatusTerminatedWhereAlaska, Illinois and Ohio
- Medical device recall Guider Softip XF Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product. Class IIFDA’s classNov 9, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedNov 9, 2016ClassClass IIStatusTerminatedWhereAlaska, Illinois and Ohio
- Medical device recall Guider Softip XF Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product. Class IIFDA’s classNov 9, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedNov 9, 2016ClassClass IIStatusTerminatedWhereAlaska, Illinois and Ohio
- Medical device recall Guider Softip XF Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product. Class IIFDA’s classNov 9, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedNov 9, 2016ClassClass IIStatusTerminatedWhereAlaska, Illinois and Ohio
- Medical device recall Guider Softip XF Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product. Class IIFDA’s classNov 9, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedNov 9, 2016ClassClass IIStatusTerminatedWhereAlaska, Illinois and Ohio
- Medical device recall Guider Softip XF Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product. Class IIFDA’s classNov 9, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedNov 9, 2016ClassClass IIStatusTerminatedWhereAlaska, Illinois and Ohio
- Medical device recall Guider Softip XF Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product. Class IIFDA’s classNov 9, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedNov 9, 2016ClassClass IIStatusTerminatedWhereAlaska, Illinois and Ohio
- Medical device recall Guider Softip XF Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product. Class IIFDA’s classNov 9, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedNov 9, 2016ClassClass IIStatusTerminatedWhereAlaska, Illinois and Ohio
- Medical device recall Guider Softip XF Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product. Class IIFDA’s classNov 9, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedNov 9, 2016ClassClass IIStatusTerminatedWhereAlaska, Illinois and Ohio
- Medical device recall Guider Softip XF Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product. Class IIFDA’s classNov 9, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedNov 9, 2016ClassClass IIStatusTerminatedWhereAlaska, Illinois and Ohio
- Medical device recall Guider Softip XF Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product. Class IIFDA’s classNov 9, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedNov 9, 2016ClassClass IIStatusTerminatedWhereAlaska, Illinois and Ohio
- Medical device recall Guider Softip XF Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product. Class IIFDA’s classNov 9, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedNov 9, 2016ClassClass IIStatusTerminatedWhereAlaska, Illinois and Ohio
- Medical device recall Heater Cooler Unit Usage: The Heater-Cooler Unit (HCU 30) supplies temperature-controlled water for… There is the potential for contaminated water to enter parts of the Heater-Cooler Unit circuits. Class IIFDA’s classNov 9, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 9, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Model 055: Thermophore Classic, Professional Quality, Deep-Heat Therapy Products manufactured with the SPT cord have a known failure mode of sparking,causing smoke, fire and burns. Class IIFDA’s classNov 9, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedNov 9, 2016ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall TANDEM (TM) COCR SHELL UHMWPE LINER BIPOLAR Some Bipolar shells were manufactured with an out of specification retainer groove. Class IIFDA’s classNov 9, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 9, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall TANDEM (TM) INTL COCR SHELL UHMWPE LINER BIPOLAR Some Bipolar shells were manufactured with an out of specification retainer groove. Class IIFDA’s classNov 9, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 9, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Rigid Suction Canister 3000 CC and 2000 CC. Risk of implosion when the Rigid Suction Canister is subjected to excessive negative pressure during use. Class IIFDA’s classNov 9, 2016in FDA’s Enforcement Report18 statesnamed in where it went PublishedNov 9, 2016ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Florida, Georgia, Illinois, Massachusetts, Maryland, Michigan, Missouri, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Texas and Washington
- Medical device recall Symbiq One Channel Infuser Hospira has received reports of Malfunction S205 Backup Battery Failure alarms in Symbiq v3.13 pumps. Class IIFDA’s classNov 9, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 9, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Symbiq Two Channel Infuser Hospira has received reports of Malfunction S205 Backup Battery Failure alarms in Symbiq v3.13 pumps. Class IIFDA’s classNov 9, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 9, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Infusion Set, Comfort, 23” Hosp 10 Tubing detachment Class IIFDA’s classNov 9, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedNov 9, 2016ClassClass IIStatusTerminatedWhereCalifornia, Indiana and Pennsylvania
- Medical device recall Contact Detach, 8mm, 23”, G29 Tubing detachment Class IIFDA’s classNov 9, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedNov 9, 2016ClassClass IIStatusTerminatedWhereCalifornia, Indiana and Pennsylvania
- Medical device recall AC TenderLink 13/30 10 pcs Tubing detachment Class IIFDA’s classNov 9, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedNov 9, 2016ClassClass IIStatusTerminatedWhereCalifornia, Indiana and Pennsylvania
- Medical device recall Comfort 5+5 Pack w/110cm Tube & 17mm Cann Tubing detachment Class IIFDA’s classNov 9, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedNov 9, 2016ClassClass IIStatusTerminatedWhereCalifornia, Indiana and Pennsylvania
- Medical device recall Silhouette Paradigm 13mm, 18” Tubing detachment Class IIFDA’s classNov 9, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedNov 9, 2016ClassClass IIStatusTerminatedWhereCalifornia, Indiana and Pennsylvania
- Medical device recall SureT G29 6mm, 18”, Paradigm Tubing detachment Class IIFDA’s classNov 9, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedNov 9, 2016ClassClass IIStatusTerminatedWhereCalifornia, Indiana and Pennsylvania
- Medical device recall Roche/Hitachi MODULAR Analytics Combination Systems Modular D/P: Clinical Chemistry Analyzer, Chemistry… Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. Class IIFDA’s classNov 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall cobas e411 Immunoassay Analyzer e411: Immunoassay Analyzer Product Usage: The cobas p501/p701 instrument… Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. Class IIFDA’s classNov 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 2, 2016ClassClass IIStatusTerminatedWhereNationwide
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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